Top

Published in:

Open Access 01-12-2024 | Endoprosthesis | Study protocol

Vitamin E-enriched medium cross-linked polyethylene in total knee arthroplasty (VIKEP): clinical outcome, oxidation profile, and wear analysis in comparison to standard polyethylene—study protocol for a randomized controlled trial

Authors: Kristin Maier, Marius Selig, Andréa Haddouche, Martin Haunschild, Oliver Hauschild, Iman Khalili, Julia Kirschberg, Christoph Lutter, Michael Menges, Patrice Mertl, Andreas Niemeier, Brice Rubens-Duval, Wolfram Mittelmeier

Published in: Trials | Issue 1/2024

Abstract

Background

The gliding surface of total knee endoprostheses is exposed to high loads due to patient weight and activity. These implant components are typically manufactured from ultra-high molecular weight polyethylene (UHMWPE). Crosslinking of UHMWPE by ionizing radiation results in higher wear resistance but induces the formation of free radicals which impair mechanical properties after contact with oxygen. Medium-crosslinked UHMWPE enriched with vitamin E (MXE) provides a balance between the parameters for a sustainable gliding surface, i.e., mechanical strength, wear resistance, particle size, and oxidation stability. Therefore, a gliding surface for knee endoprostheses made up from this material was developed, certified, and launched. The aim of this study is to compare this new gliding surface to the established predecessor in a non-inferiority design.

Methods

This multicenter, binational randomized controlled trial will enroll patients with knee osteoarthritis eligible for knee arthroplasty with the index device. Patients will be treated with a knee endoprosthesis with either MXE or a standard gliding surface. Patients will be blinded regarding their treatment. After implantation of the devices, patients will be followed up for 10 years. Besides clinical and patient-related outcomes, radiological data will be collected. In case of revision, the gliding surface will be analyzed biomechanically and regarding the oxidative profile.

Discussion

The comparison between MXE and the standard gliding surface in this study will provide clinical data to confirm preceding biomechanical results in vivo. It is assumed that material-related differences will be identified, i.e., that the new material will be less sensitive to wear and creep. This may become obvious in biomechanical analyses of retrieved implants from revised patients and in radiologic analyses.

Trial registration

ClinicalTrials.gov, NCT04618016. Registered 27 October 2020, https://clinicaltrials.gov/study/NCT04618016?term=vikep&checkSpell=false&rank=1.

All items from the World Health Organization Trial Registration Data Set can be found in Additional file 1.

Available only for authorised users

Grimberg A, Lützner J, Melsheimer O, Morlock M, Steinbrück A. Jahresbericht 2022: Mit Sicherheit mehr Qualität. 2022nd ed. Berlin: EPRD Deutsche Endoprothesenregister; 2022.

Johnson CA, White CC, Kunkle BF, Eichinger JK, Friedman RJ. Effects of the obesity epidemic on total hip and knee arthroplasty demographics. J Arthroplasty. 2021;36(9):3097–100.CrossRefPubMed

Bistolfi A, Giustra F, Bosco F, Sabatini L, Aprato A, Bracco P, et al. Ultra-high molecular weight polyethylene (UHMWPE) for hip and knee arthroplasty: the present and the future. J Orthop. 2021;25:98–106.CrossRefPubMedPubMedCentral

Currier JH, Currier BH, Abdel MP, Berry DJ, Titus AJ, van Citters DW. What factors drive polyethylene wear in total knee arthroplasty?: results of a large retrieval series. Bone Joint J. 2021;103-B(11):1695–701.CrossRefPubMed

Lambert B, Neut D, van der Veen HC, Bulstra SK. Effects of vitamin E incorporation in polyethylene on oxidative degradation, wear rates, immune response, and infections in total joint arthroplasty: a review of the current literature. Int Orthop. 2019;43(7):1549–57.CrossRefPubMed

Kurtz SM, Gawel HA, Patel JD. History and systematic review of wear and osteolysis outcomes for first-generation highly crosslinked polyethylene. Clin Orthop Relat Res. 2011;469(8):2262–77.CrossRefPubMedPubMedCentral

Wang X, Quinn PJ. The location and function of vitamin E in membranes (review). Mol Membr Biol. 2000;17(3):143–56.CrossRefPubMed

Wolf C, Macho C, Lederer K. Accelerated ageing experiments with crosslinked and conventional ultra-high molecular weight polyethylene (UHMW-PE) stabilised with alpha-tocopherol for total joint arthroplasty. J Mater Sci Mater Med. 2006;17(12):1333–40.CrossRefPubMed

Haider H, Weisenburger JN, Kurtz SM, Rimnac CM, Freedman J, Schroeder DW, et al. Does vitamin E-stabilized ultrahigh-molecular-weight polyethylene address concerns of cross-linked polyethylene in total knee arthroplasty? J Arthroplasty. 2012;27(3):461–9.CrossRefPubMed

10.

Micheli BR, Wannomae KK, Lozynsky AJ, Christensen SD, Muratoglu OK. Knee simulator wear of vitamin E stabilized irradiated ultrahigh molecular weight polyethylene. J Arthroplasty. 2012;27(1):95–104.CrossRefPubMed

11.

Schwiesau J, Fritz B, Kutzner I, Bergmann G, Grupp TM. CR TKA UHMWPE wear tested after artificial aging of the vitamin E treated gliding component by simulating daily patient activities. Biomed Res Int. 2014;2014:567374.CrossRefPubMedPubMedCentral

12.

Nebergall AK, Greene ME, Laursen MB, Nielsen PT, Malchau H, Troelsen A. Vitamin E diffused highly cross-linked polyethylene in total hip arthroplasty at five years: a randomised controlled trial using radiostereometric analysis. Bone Joint J. 2017;99-B(5):577–84.CrossRefPubMed

13.

Galea VP, Rojanasopondist P, Laursen M, Muratoglu OK, Malchau H, Bragdon C. Evaluation of vitamin E-diffused highly crosslinked polyethylene wear and porous titanium-coated shell stability: a seven-year randomized control trial using radiostereometric analysis. Bone Joint J. 2019;101-B(7):760–7.CrossRefPubMed

14.

Kjærgaard K, Ding M, Jensen C, Bragdon C, Malchau H, Andreasen CM, et al. Vitamin E-doped total hip arthroplasty liners show similar head penetration to highly cross-linked polyethylene at five years: a multi-arm randomized controlled trial. Bone Joint J. 2020;102-B(10):1303–10.CrossRefPubMedPubMedCentral

15.

Baghdadi J, Alkhateeb S, Roth A, Jäger M. Cup positioning and its effect on polyethylene wear of vitamin E- and non-vitamin E-supplemented liners in total hip arthroplasty: radiographic outcome at 5-year follow-up. Arch Orthop Trauma Surg. 2023;143(3):1679–88.CrossRefPubMed

16.

Massier JRA, van Erp JHJ, Snijders TE, de Gast A. A vitamin E blended highly cross-linked polyethylene acetabular cup results in less wear: 6-year results of a randomized controlled trial in 199 patients. Acta Orthop. 2020;91(6):705–10.CrossRefPubMedPubMedCentral

17.

Shareghi B, Johanson P-E, Kärrholm J. Wear of vitamin E-infused highly cross-linked polyethylene at five years. J Bone Joint Surg Am. 2017;99(17):1447–52.CrossRefPubMed

18.

Flament EM, Berend KR, Hurst JM, Morris MJ, Adams JB, Lombardi AV. Early Experience with vitamin E antioxidant-infused highly cross-linked polyethylene inserts in primary total knee arthroplasty. Surg Technol Int. 2016;29:334–40.PubMed

19.

Takemura S, Minoda Y, Sugama R, Ohta Y, Nakamura S, Ueyama H, et al. Comparison of a vitamin E-infused highly crosslinked polyethylene insert and a conventional polyethylene insert for primary total knee arthroplasty at two years postoperatively. Bone Joint J. 2019;101-B(5):559–64.CrossRefPubMed

20.

Ftaita S, Vanden Berghe A, Thienpont E. Vitamin E-enriched polyethylene bearings are not inferior to Arcom bearings in primary total knee arthroplasty at medium-term follow-up. Arch Orthop Trauma Surg. 2021;141(6):1027–33.CrossRefPubMed

21.

Orita K, Minoda Y, Sugama R, Ohta Y, Ueyama H, Takemura S, et al. Vitamin E-infused highly cross-linked polyethylene did not reduce the number of in vivo wear particles in total knee arthroplasty. Bone Joint J. 2020;102-B(11):1527–34.CrossRefPubMed

22.

Spece H, Schachtner JT, MacDonald DW, Klein GR, Mont MA, Lee G-C, et al. Reasons for revision, oxidation, and damage mechanisms of retrieved vitamin E-stabilized highly crosslinked polyethylene in total knee arthroplasty. J Arthroplasty. 2019;34(12):3088–93.CrossRefPubMedPubMedCentral

23.

Lizaur-Utrilla A, Gonzalez-Parreño S, Martinez-Mendez D, Miralles-Muñoz FA, Lopez-Prats FA. Minimal clinically important differences and substantial clinical benefits for Knee Society Scores. Knee Surg Sports Traumatol Arthrosc. 2020;28(5):1473–8.CrossRefPubMed

24.

Fuchs A, Häussermann P, Hömig D, Ochs BG, Müller CA, Helwig P, et al. 5-Jahres-Follow-up von 210 Columbus-Knietotalendoprothesen: Eine prospektive multizentrische Studie. Orthopade. 2018;47(10):859–66.CrossRefPubMed

25.

Puente Reyna AL, Fritz B, Schwiesau J, Schilling C, Summer B, Thomas P, et al. Metal ion release barrier function and biotribological evaluation of a zirconium nitride multilayer coated knee implant under highly demanding activities wear simulation. J Biomech. 2018;79:88–96.CrossRefPubMed

26.

Reich J, Hovy L, Lindenmaier H-L, Zeller R, Schwiesau J, Thomas P, et al. Präklinische Ergebnisse beschichteter Knieimplantate für Allergiker. Orthopade. 2010;39(5):495–502.CrossRefPubMed

27.

Thomsen M, Rozak M, Thomas P. Pain in a chromium-allergic patient with total knee arthroplasty: disappearance of symptoms after revision with a special surface-coated TKA–a case report. Acta Orthop. 2011;82(3):386–8.CrossRefPubMedPubMedCentral

28.

Thomas P, Hisgen P, Kiefer H, Schmerwitz U, Ottersbach A, Albrecht D, et al. Blood cytokine pattern and clinical outcome in knee arthroplasty patients: comparative analysis 5 years after standard versus “hypoallergenic” surface coated prosthesis implantation. Acta Orthop. 2018;89(6):646–51.CrossRefPubMedPubMedCentral

29.

Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989;248:13–4.CrossRef

30.

Rich JT, Neely JG, Paniello RC, Voelker CCJ, Nussenbaum B, Wang EW. A practical guide to understanding Kaplan-Meier curves. Otolaryngol Head Neck Surg. 2010;143(3):331–6.CrossRefPubMedPubMedCentral

31.

Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998;80(1):63–9.CrossRefPubMed

32.

Devlin N, Finch AP, Parkin D. Value sets for EQ-5D-5L: a compendium, comparative review & user guide: guidance to users of EQ-5D-5L value sets. Cham (CH); 2022. ISBN 978-3-030-89288-3.

33.

Lutter C, Grupp T, Mittelmeier W, Selig M, Grover P, Dreischarf M et al. Akkurate Abriebbestimmung bei Standardröntgenaufnahmen nach einer Knieendoprothese mittels 2D-3D-Registrierung und künstlicher Intelligenz: Eine In-Vivo-Validierung [German Medical Science GMS Publishing House]. Deutscher Kongress für Orthopädie und Unfallchirurgie (DKOU 2021); 2021. https://doi.org/10.3205/21dkou354.

34.

Grupp TM, Fritz B, Kutzner I, Schilling C, Bergmann G, Schwiesau J. Vitamin E stabilised polyethylene for total knee arthroplasty evaluated under highly demanding activities wear simulation. Acta Biomater. 2017;48:415–22.CrossRefPubMed

35.

Schwiesau J, Fritz B, Bergmann G, Puente Reyna AL, Schilling C, Grupp TM. Influence of radiation conditions on the wear behaviour of Vitamin E treated UHMWPE gliding components for total knee arthroplasty after extended artificial aging and simulated daily patient activities. J Mech Behav Biomed Mater. 2021;122:104652.CrossRefPubMed

36.

Klebingat S, Bien T, Hürtgen J, Grover P, Dreischarf M, Alkhateeb S, et al. Accurate determination of hip implant wear, cup anteversion and inclination through AI automated 2D–3D registration. J Orthop Res. 2023;41(9):1985–95.CrossRefPubMed

Title: Vitamin E-enriched medium cross-linked polyethylene in total knee arthroplasty (VIKEP): clinical outcome, oxidation profile, and wear analysis in comparison to standard polyethylene—study protocol for a randomized controlled trial
Authors: Kristin Maier
Marius Selig
Andréa Haddouche
Martin Haunschild
Oliver Hauschild
Iman Khalili
Julia Kirschberg
Christoph Lutter
Michael Menges
Patrice Mertl
Andreas Niemeier
Brice Rubens-Duval
Wolfram Mittelmeier
Publication date: 01-12-2024
Publisher: BioMed Central
Keyword: Endoprosthesis
Published in: Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-023-07811-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Vitamin E-enriched medium cross-linked polyethylene in total knee arthroplasty (VIKEP): clinical outcome, oxidation profile, and wear analysis in comparison to standard polyethylene—study protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2024

Preoperative supine time for adrenal venous sampling: a prospective randomized controlled trial

Study protocol for a prospective, randomized, multicenter trial to investigate the influence of peripheral nerve stimulation on patients with chronic sacroiliac joint syndrome (SILENCING)

Effect of resuscitative endovascular balloon occlusion of the aorta in nontraumatic out-of-hospital cardiac arrest: a multinational, multicenter, randomized, controlled trial

The effect of oral motor intervention with different initiation times to improve feeding outcomes in preterm infants: protocol for a single-blind, randomized controlled trial

Effectiveness of artificial intelligence vs. human coaching in diabetes prevention: a study protocol for a randomized controlled trial